1. Field of the Invention
This invention is concerned with a device and the method of using such device to prescribe a treatment regiment based on the condition of the wound, particularly when the wound is a chronic wound, most particularly pressure ulcers (sores), venous ulcers and diabetic ulcers.
2. Related Art
The healing process of wounds is widely accepted to be categorized into the following four (4) conditions (hereinafter referred to as “healing phase conditions”):
(1) necrotic; (2) fibrinous slough or infection; (3) granulation; and (4) epithelialization. The necrotic condition refers to the wound healing phase condition where catabolic processes have been resulting in dead tissue. The fibrinous slough or infection condition refers to the circumstance where the wound is in the inflammatory phase, where dead cellular debris fills the base of the wound with an off-white to yellow layer. The granulation condition refers to the healing phase when the wound has reached the proliferative stage of healing and when the wound cavity is slowly filled with the “repair-material” of the body which consists of fibro-vascular tissue and is called granulation. The epithelialization condition describes the wound healing phase wherein the keratinocytes (epidermal cells) are dividing and gradually crossing the wound surface from the margins towards the opposite side. Once the cells make contact with each other the cells stop dividing (contact inhibition).
The foregoing healing phase conditions have also been depicted by a widely accepted color classification scheme with the necrotic condition depicted by the color black; the fibrinous slough or infection condition depicted by the color yellow; the granulation condition shown by the color red; and the epithelialization condition depicted by the color pink.
A second condition important in the healing process of the wound is the wound's moisture condition or level (hereinafter referred to as “moisture condition”). It has been identified as early as 1962 (see Winter, “Formation of the Scab and the Rate of Epithelialization in the Skin of the Domestic Pig”, Nature; 193: 293-294 (1962) that wound healing occurs faster in a “moist” environment as opposed to a dry or wet environment. If the environment is too dry, it is believed that the wound does not heal as quickly because in a healing wound, most of the processes involved are driven by cells (e.g., specific leucocytes such as Poly Morpho Nuclear's (PMN's)). These cells need a moist environment to stay alive for their biological work. When the wound is too wet, maceration of the skin cells occurs which cause cell death by the cells literally bursting from taking up too much fluid.
The moisture condition of the wound has also been depicted by color schemes with the color yellow depicting the dry condition (yellow conjuring up the impression of the dryness of the desert); the color blue being used to depict the wet condition (blue conjuring up the image of the wetness of the ocean); and the color green being used to represent the moist condition (green conjuring the likeness of an oasis).
The foregoing healing phase conditions and moisture conditions with the described color schemes and recommended wound treatment have been depicted in graphical form in the copyrighted and trademarked drawing entitled “The Natural Line of Wound Healing” provided by Johnson & Johnson. {See FIG. 6} This conceptual model visualizes the way in which the healing process takes place in chronic wounds. Specifically, the “S-shaped” curve of the graph depicts the healing phase condition of the wound with the lower left-hand part of the curve representing the necrotic phase (darkened area appearing black); moving along the curve upwards, the yellow region representing the sloughy healing phase; moving yet further up the curve -and crossing over the horizontal green line, the red region of the curve representing the granulation healing phase; and continuing up the curve to the pink region representing the epithelialization phase of the wound. Likewise, the wet or macerated condition of a wound is illustrated by the blue region under the horizontal green line. The horizontal green line representing the ideal “moist” wound moisture level. Above the green line, is the dry (dehydrated) region depicted by the color yellow. While this graph provides a useful and illustrative tool in assessing the healing phase and moisture conditions of the wound and prescribing a wound treatment regiment, a more simplified tool was desired.
The present invention makes use of a “slide rule format” as hereinafter described to provide a simple and illustrative method of determining the treatment regiment based on the healing phase condition and moisture condition for the wound.
Slide rule formats have been known to assist in calculations and to produce many things including the manufacture of springs (see U.S. Pat. No. 3,570,757); estimates for concrete mix proportions of air, cement, water, fine and coarse aggregates (see U.S. Pat. No. 3,814,308); guidelines for intravenous therapy (see, U.S. Pat. No. 3,747,847); and for computing hyper-alimentation dosages (see, U.S. Pat. No. 4,189,634). However, Applicants are unaware of the use of any slide rule format based on the healing phase and moisture conditions of chronic wounds for the purpose of following a treatment regiment for such wounds.